GALANTAMINE

Product Information

Labeler Name

AUROBINDO PHARMA LIMITED

Name of Company corresponding to the labeler code segment of the ProductNDC.

Product Type Name

HUMAN PRESCRIPTION DRUG

Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Non Proprietary Name

GALANTAMINE

Sometimes called the generic name, this is usually the active ingredient(s) of the product.

Proprietary Name

GALANTAMINE

Also known as the trade name. It is the name of the product chosen by the labeler.

Proprietary Name Suffix

N/S (NOT SPECIFIED)

A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.

Status

ACTIVE

NDC Code Status:

ActiveActive NDC Code

DeprecatedDeprecated NDC Code

Unfinished (Unapproved) The following status describes submitted unfinished drugs,
including the marketing categories of Active Pharmaceutical Ingredient (API),
Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding.
FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.

DEA Schedule

N/S (NOT SPECIFIED)

This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Drug Package Information

NDC Package Code

65862-746-90

The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.

Package Description

90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (65862-746-90)

A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.

Sample Package

N

Defines whether given package serves sample purposes.

Package NDC Exclude Flag

N

This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Package Start Marketing Date

20160805

This is the date that the labeler indicates was the start of its marketing of the drug package.

Package End Marketing Date

N/S (NOT SPECIFIED)

This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information

Product NDC

65862-746

The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.

11 Digit NDC Code

65862-0746-90

It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.

Application Number

ANDA204895

This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category Name

ANDA

Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Listing Record Certified Through

20191231

This is the date when the listing record will expire if not updated or certified by the firm.

Product Marketing Start Date

20160805

This is the date that the labeler indicates was the start of its marketing of the drug product.

Product Marketing End Date

N/S (NOT SPECIFIED)

This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product NDC Exclude Flag

N

This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Route, Substance, Strength, & Dosage

Route Name

ORAL

The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Pharmaceutical Classes

CHOLINESTERASE INHIBITOR [EPC],CHOLINESTERASE INHIBITORS [MOA]

These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance Name

GALANTAMINE HYDROBROMIDE

This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Strength Number

24

These are the strength values (to be used with units below) of each active ingredient, listed in the same order as the SubstanceName field above.

Strength Unit

MG/1

These are the units to be used with the strength values above, listed in the same order as the SubstanceName and SubstanceNumber.

Dosage Form Name

CAPSULE, EXTENDED RELEASE

The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.

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